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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm November 19, 2004
Date Posted December 28, 2004
Recall Status1 Terminated 3 on June 07, 2005
Recall Number Z-0372-05
Recall Event ID 30462
510(K)Number K012210  
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product ACCU-CHEK Inform meter; catalog No. 3035123.
Code Information All units with firmware version 2.3 that have the OTE (other test entry) functionality enabled.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-440-3638
Manufacturer Reason
for Recall		 A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa.
FDA Determined
Cause 2		 Other
Action Consignees were notified via a letter dated 11/19/04, which instructed them to discontinue using the OTE functionality.
Quantity in Commerce 4697
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = ROCHE DIAGNOSTICS CORP.
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